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BOSTON – The recently passed 21st Century Cures Act has large implications for the pharmaceutical and medical device industry even if the impact will be better understood through the actions of the new presidential administration, according to the 2017 AGA Tech Summit keynote speaker.
“The Cures Act is a huge document with an array of provisions that seeks, among other goals, to create a pathway to streamline the [Food and Drug Administration] and the regulatory process,” Herbert Lerner, MD, senior director of regulatory and clinical sciences at the law firm Hogan Lovells in Washington, explained in an interview.
In his keynote address at the meeting, sponsored by the AGA Center for GI Innovation and Technology, Dr. Lerner described the 21st Century Cures Act with an emphasis on its intent relative to regulatory compliance by the device industry. As law, the provisions of the Act are relevant to planning for regulatory review of new products, but Dr. Lerner acknowledged that the health care industry should be considering both the intent of the Act and how it may unfold under the budgetary cuts planned by the current administration.
“One consequence of the current hiring freeze may result in personnel shortages that could substantially impact the ability of the FDA to perform its functions,” Dr. Lerner cautioned. In addition, he cited the emphasis placed by the administration on reducing the burden of regulation that surpasses the scope of the Cures Act.
“The new President has asked that two regulations be eliminated for any new regulation that is proposed. It is hard to predict how this would impact the FDA if it was enforced,” Dr. Lerner reported.
Passed after 2 years of political wrangling, the Cures Act addresses a wide spectrum of health policy, including increasing funding for cancer research, care of the mentally ill, and treatment of opioid addiction, but Dr. Lerner concentrated on the portions most likely to affect the medical tech industry. For example, he dissected provisions that have renewed the emphasis on the selection of experts serving on advisory panels that provide recommendations to the FDA on new product approvals, the language that has addressed the idea of centralized institutional review boards for clinical trials for device manufacturers, and new regulations outlining provisions that may affect how the industry addresses changes to devices that have already been marketed.
“There are important changes in a number of aspects of the regulatory process mandated by the Cures Act that will impose a meaningful effect on how the medical device and drug industry pursue new products or execute regulatory compliance with existing products,” Dr. Lerner said. The Cures Act also provides language to cover new directions in health care such as the exploding use of mobile medical apps to monitor health.
Understanding the intent of the Cures Act, which had substantial support by both major political parties, is important even if it is now unclear whether all parts of the Act will be implemented as planned under a new administration, according to Dr. Lerner. He suggested that support for a streamlined and more efficient FDA was the force behind the changes in regulatory review included in this new Act. Change is underway even if a complete understanding of how these changes will be enacted remains unclear.
Based on current staff shortages and expected budget cuts at the FDA, it does appear that the review process for submissions of devices will grow longer even if the Cures Act has been designed to streamline the process. Dr. Lerner, acknowledging this paradox, suggested that companies planning to submit an application for a new device to the FDA be particularly rigorous in ensuring that the application is complete.
“Spend a little extra time to make sure that what you are sending in is as good as it can be,” Dr. Lerner offered to industry representatives working in the evolving environment. He cautioned that with the expected additional time taken for regulatory review, revisions and resubmissions are likely to compound delays.
AGA supported passage of the 21st Century Cures Act and will continue to work with Congress to help ensure the regulations continue encouraging innovation, while also helping the gastroenterology community determine which treatments work best for patients.
BOSTON – The recently passed 21st Century Cures Act has large implications for the pharmaceutical and medical device industry even if the impact will be better understood through the actions of the new presidential administration, according to the 2017 AGA Tech Summit keynote speaker.
“The Cures Act is a huge document with an array of provisions that seeks, among other goals, to create a pathway to streamline the [Food and Drug Administration] and the regulatory process,” Herbert Lerner, MD, senior director of regulatory and clinical sciences at the law firm Hogan Lovells in Washington, explained in an interview.
In his keynote address at the meeting, sponsored by the AGA Center for GI Innovation and Technology, Dr. Lerner described the 21st Century Cures Act with an emphasis on its intent relative to regulatory compliance by the device industry. As law, the provisions of the Act are relevant to planning for regulatory review of new products, but Dr. Lerner acknowledged that the health care industry should be considering both the intent of the Act and how it may unfold under the budgetary cuts planned by the current administration.
“One consequence of the current hiring freeze may result in personnel shortages that could substantially impact the ability of the FDA to perform its functions,” Dr. Lerner cautioned. In addition, he cited the emphasis placed by the administration on reducing the burden of regulation that surpasses the scope of the Cures Act.
“The new President has asked that two regulations be eliminated for any new regulation that is proposed. It is hard to predict how this would impact the FDA if it was enforced,” Dr. Lerner reported.
Passed after 2 years of political wrangling, the Cures Act addresses a wide spectrum of health policy, including increasing funding for cancer research, care of the mentally ill, and treatment of opioid addiction, but Dr. Lerner concentrated on the portions most likely to affect the medical tech industry. For example, he dissected provisions that have renewed the emphasis on the selection of experts serving on advisory panels that provide recommendations to the FDA on new product approvals, the language that has addressed the idea of centralized institutional review boards for clinical trials for device manufacturers, and new regulations outlining provisions that may affect how the industry addresses changes to devices that have already been marketed.
“There are important changes in a number of aspects of the regulatory process mandated by the Cures Act that will impose a meaningful effect on how the medical device and drug industry pursue new products or execute regulatory compliance with existing products,” Dr. Lerner said. The Cures Act also provides language to cover new directions in health care such as the exploding use of mobile medical apps to monitor health.
Understanding the intent of the Cures Act, which had substantial support by both major political parties, is important even if it is now unclear whether all parts of the Act will be implemented as planned under a new administration, according to Dr. Lerner. He suggested that support for a streamlined and more efficient FDA was the force behind the changes in regulatory review included in this new Act. Change is underway even if a complete understanding of how these changes will be enacted remains unclear.
Based on current staff shortages and expected budget cuts at the FDA, it does appear that the review process for submissions of devices will grow longer even if the Cures Act has been designed to streamline the process. Dr. Lerner, acknowledging this paradox, suggested that companies planning to submit an application for a new device to the FDA be particularly rigorous in ensuring that the application is complete.
“Spend a little extra time to make sure that what you are sending in is as good as it can be,” Dr. Lerner offered to industry representatives working in the evolving environment. He cautioned that with the expected additional time taken for regulatory review, revisions and resubmissions are likely to compound delays.
AGA supported passage of the 21st Century Cures Act and will continue to work with Congress to help ensure the regulations continue encouraging innovation, while also helping the gastroenterology community determine which treatments work best for patients.
BOSTON – The recently passed 21st Century Cures Act has large implications for the pharmaceutical and medical device industry even if the impact will be better understood through the actions of the new presidential administration, according to the 2017 AGA Tech Summit keynote speaker.
“The Cures Act is a huge document with an array of provisions that seeks, among other goals, to create a pathway to streamline the [Food and Drug Administration] and the regulatory process,” Herbert Lerner, MD, senior director of regulatory and clinical sciences at the law firm Hogan Lovells in Washington, explained in an interview.
In his keynote address at the meeting, sponsored by the AGA Center for GI Innovation and Technology, Dr. Lerner described the 21st Century Cures Act with an emphasis on its intent relative to regulatory compliance by the device industry. As law, the provisions of the Act are relevant to planning for regulatory review of new products, but Dr. Lerner acknowledged that the health care industry should be considering both the intent of the Act and how it may unfold under the budgetary cuts planned by the current administration.
“One consequence of the current hiring freeze may result in personnel shortages that could substantially impact the ability of the FDA to perform its functions,” Dr. Lerner cautioned. In addition, he cited the emphasis placed by the administration on reducing the burden of regulation that surpasses the scope of the Cures Act.
“The new President has asked that two regulations be eliminated for any new regulation that is proposed. It is hard to predict how this would impact the FDA if it was enforced,” Dr. Lerner reported.
Passed after 2 years of political wrangling, the Cures Act addresses a wide spectrum of health policy, including increasing funding for cancer research, care of the mentally ill, and treatment of opioid addiction, but Dr. Lerner concentrated on the portions most likely to affect the medical tech industry. For example, he dissected provisions that have renewed the emphasis on the selection of experts serving on advisory panels that provide recommendations to the FDA on new product approvals, the language that has addressed the idea of centralized institutional review boards for clinical trials for device manufacturers, and new regulations outlining provisions that may affect how the industry addresses changes to devices that have already been marketed.
“There are important changes in a number of aspects of the regulatory process mandated by the Cures Act that will impose a meaningful effect on how the medical device and drug industry pursue new products or execute regulatory compliance with existing products,” Dr. Lerner said. The Cures Act also provides language to cover new directions in health care such as the exploding use of mobile medical apps to monitor health.
Understanding the intent of the Cures Act, which had substantial support by both major political parties, is important even if it is now unclear whether all parts of the Act will be implemented as planned under a new administration, according to Dr. Lerner. He suggested that support for a streamlined and more efficient FDA was the force behind the changes in regulatory review included in this new Act. Change is underway even if a complete understanding of how these changes will be enacted remains unclear.
Based on current staff shortages and expected budget cuts at the FDA, it does appear that the review process for submissions of devices will grow longer even if the Cures Act has been designed to streamline the process. Dr. Lerner, acknowledging this paradox, suggested that companies planning to submit an application for a new device to the FDA be particularly rigorous in ensuring that the application is complete.
“Spend a little extra time to make sure that what you are sending in is as good as it can be,” Dr. Lerner offered to industry representatives working in the evolving environment. He cautioned that with the expected additional time taken for regulatory review, revisions and resubmissions are likely to compound delays.
AGA supported passage of the 21st Century Cures Act and will continue to work with Congress to help ensure the regulations continue encouraging innovation, while also helping the gastroenterology community determine which treatments work best for patients.
FROM THE 2017 AGA TECH SUMMIT